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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child with neuro-motor diagnosis (e.g., CP, hypoxia, etc.)
Children aged 3-9 years, and parents/guardians aged 18+
Must not have
Compromised airway
Uncontrolled seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effectiveness of aquatic therapy for children 3-9 with neuromotor deficits, like cerebral palsy. Twice a week in a warm water pool for 10 weeks.
Who is the study for?
This trial is for children aged 3-9 with neuromotor issues like cerebral palsy or brain hypoxia, who have trouble using their arms and doing self-care tasks. Their parents or guardians must be over 18. Kids can't join if they have breathing problems or seizures that aren't under control.
What is being tested?
The study tests aquatic therapy in a warm pool, focusing on swim safety, improving arm use, and helping kids do everyday activities by themselves. It involves going to the pool twice a week for ten weeks.
What are the potential side effects?
Aquatic therapy is generally gentle but may include risks like minor injuries from slips or falls, muscle soreness from exercises, skin reactions to chlorine in the water, and fatigue after sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has a diagnosis affecting their brain and muscle function.
Select...
I am a parent/guardian over 18 or a child between 3-9 years old.
Select...
My child has difficulty using their arms or hands.
Select...
My child struggles with daily self-care activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have trouble breathing due to a blocked airway.
Select...
I have seizures that are not controlled by medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
Change in Quality of Upper Extremity Skills Test (QUEST)
Change in Water Orientation Test Alyn (WOTA)
Secondary study objectives
Change in Canadian Occupational Performance Measure (COPM)
Change in Participation and Environment Measure (PEM-CY)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention: aquatic occupational therapy (AquOTic-NM)Experimental Treatment1 Intervention
aquatic occupational therapy 30 minutes, self care training 15 minutes
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,121 Total Patients Enrolled
Franklin County Board of Developmental DisabilitiesUNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a diagnosis affecting their brain and muscle function.I am a parent/guardian over 18 or a child between 3-9 years old.My child has difficulty using their arms or hands.I have trouble breathing due to a blocked airway.I have seizures that are not controlled by medication.My child struggles with daily self-care activities.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention: aquatic occupational therapy (AquOTic-NM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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